Evaluation of Preoperative Gastric Ultrasonography in Pediatric Patients in Terms of Patient Safety

NCT07581691 | Recruiting

• 1 other identifier: 2024/163
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Preoperative evaluation of stomach fullness with ultrasound in children who will undergo anesthesia outside the operating room

Conditions

Nonoperating Room Anesthesia; Gastric Ultrasound

Keywords

nonoperating room anesthesia; pediatric nonoperating room anesthesia; gastric ultrasound

Outcome Measures

Primary Outcomes (1)

• Qualitative assessment of residual gastric fluid volume

  Grade 0: Defined as no contents visible in the antrum, the stomach is empty and the volume of the contents approaches zero. Grade 1: Visible clear fluid with a fluid volume of \<1.5 mL/kg. Grade 2: Defined as visible clear fluid with a fluid volume of \>1.5 mL/kg in both the supine and lateral decubitus positions.

  preoperative evaluation in the operating room

Secondary Outcomes (2)

• Gastric content volume

  preoperative evaluation in the operating room

• Antral cross-sectional area

  preoperative evaluation in the operating room

Study Arms (1)

Group undergoing gastric ultrasound

Children between 0-18 years of age and ASA I-II patients will be included in the study. Stomach contents and volume will be determined with ultrasound and the postoperative effects of the values found will be examined. Gastric ultrasound will be performed before anesthesia induction, with children in the supine and lateral decubitus positions, using either a linear high-frequency or abdominal probe, depending on the age of the child, to obtain a sagittal section of the antrum in a plane that includes the left lobe of the liver and the aorta.

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

ASA I-II children aged 0-18 years who underwent non-operating room anesthesia

You may qualify if:

• Children between 0-18 years of age and ASA I-II patients will be included in the study.

You may not qualify if:

• Patients over 18 years of age,
• ASA-III and above patients,
• patients with gastrointestinal dysfunction,
• patients who cannot assume the lateral decubitus position for gastric -ultrasound measurements,
• those who have had previous lower esophageal or gastric surgery,
• those who do not comply with institutional fasting guidelines,
• those with concomitant systemic diseases affecting gastric emptying,
• those with a high body mass index (BMI) \> 40 kg/m2,
• those with gastroesophageal reflux or aspiration risk factors, and emergency cases with delayed gastric emptying despite appropriate fasting time will not be included in the study.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Özlem OZ GERGIN, MD

CONTACT

09005332466396; oozgergin@erciyes.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: November 15, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)